BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1050263 · Received May 22, 2008

    Report

    Report Number
    6000034-2008-00273
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 2, 2008
    Report Date
    May 22, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST IN 2008, THE PATIENT'S MOTHER REPORTED THE PATIENT HAD "PAIN DEEP INSIDE EAR RADIATING DOWN JAWLINE". REPORTEDLY, THE PAIN OCCURRED WHEN THE SOUND PROCESSOR WAS TURNED ON. THE PAIN WOULD DISSIPATE AFTER THE SOUND PROCESSOR WAS TURNED OFF. THERE WAS NO REPORTED EAR INFECTION AND A CT SCAN (DATE NOT REPORTED) SHOWED NO SIGN OF DEVICE MOVEMENT. REPROGRAMMING SHOWED SIGNIFICANT CHANGES IN DYNAMIC RANGES. THE RESULTS OF AN INTEGRITY TEST DONE IN 2004 WAS CONSISTENT WITH NORMAL RECEIVER/STIMULATOR FUNCTION. THE PATIENT DISCONTINUED USE OF THE DEVICE. THE PATIENT'S DEVICE WAS EXPLANTED TWENTY SIX DAYS AFTER THE ORIGINAL DATE, AND A NEW DEVICE WAS REIMPLANTED DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM COCHLEAR LTD. CI24RE(CA) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention